PlainRecalls
FDA Devices Moderate Class II Terminated

Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner on the inside diameter for lubricity, stainless steel wire reinforcement within the wall for torque transmission and strength, and polymer materials along the length of the catheter for support and flexibility. The catheter has an atraumatic tip and a hub/strain relief combinati

Reported: August 15, 2018 Initiated: December 11, 2017 #Z-2735-2018

Product Description

Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner on the inside diameter for lubricity, stainless steel wire reinforcement within the wall for torque transmission and strength, and polymer materials along the length of the catheter for support and flexibility. The catheter has an atraumatic tip and a hub/strain relief combination for kink resistance (at the hub), device connectivity, and device handling.

Reason for Recall

Potential polymer material degradation.

Details

Units Affected
31,005
Distribution
Worldwide - US Nationwide Distribution - AL, FL, IL, IN, KY, MA, MI, MN, MS, NC, NV, NY, OH, OR, TN, TX, UT, WA and the country CANADA
Location
Maple Grove, MN

Frequently Asked Questions

What product was recalled? ▼
Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner on the inside diameter for lubricity, stainless steel wire reinforcement within the wall for torque transmission and strength, and polymer materials along the length of the catheter for support and flexibility. The catheter has an atraumatic tip and a hub/strain relief combination for kink resistance (at the hub), device connectivity, and device handling.. Recalled by Boston Scientific Corporation. Units affected: 31,005.
Why was this product recalled? ▼
Potential polymer material degradation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 15, 2018. Severity: Moderate. Recall number: Z-2735-2018.

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